Eye Infections, BacterialPhase 1NCT00357383
Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers
A Phase 1 study testing Azithromycin (T1225) in people with Eye Infections, Bacterial, run by Laboratoires Thea.
Trial summary
To evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day 2). To assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day treatment period Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Infections, Bacterial
- What is being tested?
- Azithromycin (T1225)
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Oct 2002to Oct 2002
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged from 18 to 45 years old;
- Written informed consent;
- Healthy volunteers without any subjective ocular symptom;
- Normal ocular examination in both eyes (corrected visual acuity >= 6/10, normal slit lamp examination, tear prism height > 0.1mm, tear break-up time (BUT) >= 10 seconds, lissamine green test score < 4);
- Registered, or agreed to be registered, in the national register of healthy volunteers
Who cannot join
- Ocular trauma, infection or inflammation within the last 3 months;
- number of corneal stained punctuations Ocular trauma, infection or inflammation within the last 3 months;
- number of corneal stained punctuations >= 5;
- blepharitis, conjunctivitis, uveitis;
- contact lenses;
- topical ocular treatment within the last month;
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- ocular laser within the last 3 months;
- ocular surgery, including LASIK and PRK, within the last 12 months;
- systemic macrolide within the last month;
- medication during the study (except: paracetamol and contraceptives).
About this study
To evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day 2).
To assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day treatment period
Read the detailed description
The aim of the present study was to compare ocular tolerance and safety after repeated instillations of T1225 1% and 1.5% eye drops and vehicle and to assess the residual azithromycin concentrations in tear, ocular conjunctiva and plasma samples, approximately 12 hours after the last Investigational Medicinal Product instillation.
- Conditions
- Eye Infections, Bacterial
- Being tested
- Azithromycin (T1225)
- Medical subject headings
- Eye Infections, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin (T1225)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular pharmacokinetic in tears
Secondary outcomes (1)
Tolerance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startOct 2002
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye Infections, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Didier CHASSARD, Dr, Principal investigator, ASTER, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357383
- Sponsor's protocol ID
- LT1225-PI3-07/02(F)
- Status last verified
- Jul 2006
- First submitted
- 25 Jul 2006
- Last updated
- 27 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00357383
- Acronym / sponsor ID
- LT1225-PI3-07/02(F)
- Conditions
- Eye Infections, Bacterial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Study completion
- Oct 2002
- First posted
- 27 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day 2).
To assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day treatment period
Detailed description
The aim of the present study was to compare ocular tolerance and safety after repeated instillations of T1225 1% and 1.5% eye drops and vehicle and to assess the residual azithromycin concentrations in tear, ocular conjunctiva and plasma samples, approximately 12 hours after the last Investigational Medicinal Product instillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female aged from 18 to 45 years old;
- Written informed consent;
- Healthy volunteers without any subjective ocular symptom;
- Normal ocular examination in both eyes (corrected visual acuity >= 6/10, normal slit lamp examination, tear prism height > 0.1mm, tear break-up time (BUT) >= 10 seconds, lissamine green test score < 4);
- Registered, or agreed to be registered, in the national register of healthy volunteers
Key exclusion criteria (10 listed)
- Ocular trauma, infection or inflammation within the last 3 months;
- number of corneal stained punctuations Ocular trauma, infection or inflammation within the last 3 months;
- number of corneal stained punctuations >= 5;
- blepharitis, conjunctivitis, uveitis;
- contact lenses;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin (T1225) | Drug | – |
Primary outcome
Ocular pharmacokinetic in tears
1 secondary outcome
Tolerance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier CHASSARD, Dr principal investigator
ASTER, Paris, France
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azithromycin (T1225) in people with Eye Infections, Bacterial, run by Laboratoires Thea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular pharmacokinetic in tears. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2006.